The field of invention relates to medical devices designed to stop serious nosebleeds. There are many products on the market to stop nosebleeds but none of them work much better than putting some type of gauze packing in the nose.
There is a need for a device that will treat the severe nosebleeds or major epistaxsis that is not controlled with gauze slipped into the nose. A device is needed for nosebleeds which are not easily stopped and to replace the one or two inflatable devices, presently available, which are mostly ineffective and tend to be painful.
Part of the difficulty with nosebleeds is that the nasal chamber is not a space with flat walls where pressure can be brought to bare. Instead, the nasal cavity has what can be thought of as serpentine deep grooves, called meatus recesses, in the side walls which are fairly narrow and make it difficult to produce pressure in these recessed areas. The present devices will not easily flow into these recesses to stop a nosebleed. A new device is required that will stop nosebleeds, which do not respond to simpler methods.
Another problem must be solved when designing a device to stop the more serious nosebleed. The nasal cavity is divided by a center wall, the nasal septum, which produces right and left nasal chamber airways. This center wall extends from the anterior opening of the nose posteriorly, but eventually ends so the posterior part of the nose is just one chamber. The new invention should be capable of entering both the right and left anterior nasal chamber airways or nasal cavities.
Therefore, the nasal cavity is made up of two divided chambers anteriorly and a common chamber posteriorly. Nosebleeds can occur either in the anterior or posterior cavities. It is relatively common, especially in older people, to be unable to see where the nosebleed is originating, especially when the treating physician is not an ear, nose and throat (ENT) doctor. When a doctor cannot find the source of bleeding, he/she will commonly call the nosebleed a xe2x80x9cposterior nose bleed.xe2x80x9d The nosebleed may be in the anterior ⅔""s of the nose or in one of the recesses or in the posterior ⅓ common chamber of the nose but a persistant nosebleed is still commonly called a xe2x80x9cposterior epistaxsisxe2x80x9d.
There is a need for a device that puts more uniform pressure into the nose. Presently used devices use a balloon to xe2x80x9cblow upxe2x80x9d in the nose but the balloon does not conform to the interior configuration of the nose. The balloon device attempts to fill the nasal interior with an expanding balloon by forcing more water into the balloon, but the balloon does not expand into the serpentine recesses of the nose. These recesses in the lateral wall of the nose are individually called a meatus. Meatus can be both singular and plural when describing more than one meatus. A meatus is created by an xe2x80x9coverhang structurexe2x80x9d on the side wall of the nose called a turbinate.
One of the early methods for treatment is for an xe2x80x9canteriorxe2x80x9d nose bleed, where gauze is placed into either the right or left side of the nose, whichever is bleeding, or at times both sides of the nose. A xe2x80x9cposteriorxe2x80x9d pack can be placed into the nose in addition to the xe2x80x9canteriorxe2x80x9d gauze packing. A roll of gauze is inserted into the back of the nose and secured to a second roll of gauze at the opening of the nose with a string so the posterior gauze roll will not fall into the throat. This method is now seldom used since the Foley Catheter method was developed.
The Standard Urological Catheter (Foley Catheter) has a balloon that is expanded with water to put pressure in the back of nose, in the common space posterior to the center wall septum. This balloon also allows the physician to insert gauze into the front of the nose with less concern that the packing will fall into the throat and obstruct the airway. The catheter is clamped at the inlet of the nose to keep the balloon from moving backwards into the throat. The balloon of the Foley Catheter produces excessive pressure and pain when inflated in an attempt to fill the posterior cavity of the nose and still does not conform to or fill the entire space.
The XOMED(trademark) Epistat(trademark) (XOMED(trademark) and Epistat(trademark) are trademarks of Xomed Surgical Products Inc.) represents the latest technology used to attempt to stop the persistent nosebleed. The XOMED(trademark) Epistat(trademark) uses a catheter traversing through the right or left chamber of the nose. You could put one in each side of the nose. Two balloons are inflated with water. The larger balloon is meant to put pressure in the anterior nasal cavity that is divided into right and left side. The small balloon is meant to put pressure in the posterior chamber of the nose. This is the common chamber.
The XOMED(trademark) Epistat(trademark) has inflatable balloons where it is difficult to conform to the shapes of the nasal cavities, especially the anterior cavity. The anterior nasal cavity is the hardest to fill with a balloon. The expanding spherical or ovoid balloon will put minimal pressure in the crevices. Likewise, the posterior nasal cavity is not a sphere and the expanding bulb will not conform to the anatomical space.
In an attempt to control the bleeding, the physician will put more and more pressure in the balloons and this causes a significant amount of pain because of the expanding pressure inside the nose. The pain is produced because the balloon is expanded with much more pressure than needed to compress a bleeding vessel. The increased pressure is used to try to drive the balloon into the crevices or serpentine recesses of the nose. These recesses of the nose are the Superior Meatus, Middle Meatus and Inferior Meatus. Regardless of how much pressure is put into the balloon, the balloon will not flow into the crevices of the nose.
The XOMED(trademark) Epistat(trademark) balloon expands producing a round or ovoid configuration while producing significant pressure in a very small area, with significant pain, and does not fill much of the interior space of the nose such as the lateral crevices. There is not very effective filling of the posterior nose by the posterior balloon of the XOMED(trademark) Epistat(trademark). The balloon expands in about a sphere and takes on a modified configuration only when significant pressure is used in the balloon and it still does not fill much of the posterior airway, because the balloon does not match the anatomical configuration of the posterior nose.
The XOMED(trademark) EPISTAT II(trademark) was believed to have been produced in an attempt to stop bleeding without the need for an anterior nasal balloon. The anterior balloon is the balloon that causes most of the pain. The anterior balloon was replaced with a compressed xe2x80x9cspongexe2x80x9d which expands when inserted into the nose. Although the EPISTAT II(trademark) is much less painful, it is not very effective in stopping nosebleeds. The compressed sponge often lacks the force of expansion necessary to place sufficient pressure in the nasal cavities and recesses. There is no external force, such as water from a syringe, that drives the surface of the sponge into the recesses. Only the force of the sponge structure attempting to expand itself is available and this force is most often inadequate.
The present state of technology in medical devices for stopping serious nosebleeds is inadequate since the current devices lack the ability to effectively flow into the recesses of the anterior nasal cavity or fill the posterior nasal cavity and use severe pressure with associated intense pain. Therefore, a need exists for a new medical device that will overcome these deficiencies.
The present invention will effectively flow into the recesses of the nasal cavity without severe pressure and the associated intense pain thus filling the anterior nasal cavity, meatus and posterior nose without causing significant discomfort. The present invention will provide an improvement over existing devices that do not fill the recesses of the nose, do cause significant pain and still do not stop nosebleeds very effectively.
The objectives are achieved through the design of a nasal catheter system to stop a nosebleed coming from one or both of the nasal airways, either right and/or left nasal airways. A version of the device has two inflatable bags, which in the preferred embodiment are not elastic balloons. The anterior bag is much larger in volume than the anterior nasal cavity. The design of the bag is generally cylindrical but has deep ridges projecting outward producing a xe2x80x9cpleatedxe2x80x9d design with ribs running along and parallel to axis of the catheter. Alternate designs include a circumferential ring or capillary tube fingers projecting outward. Any surface projection that serves to create additional surface area or any projection that winds and flows into the recesses with greater ease will accomplish some aspect of the desired objective.
Traditional devices typically are spherical or ovoid shaped balloons that lack the added surface projections to flow and wiggle into the deep crevices without extreme pressure and associated severe pain to the patient. The shape and redundancy of size of the present invention will allow the anterior bag and surface projections to fill the anterior chamber and xe2x80x9cflowxe2x80x9d into the deep crevices of the nose without the need for excessive pressure and pain. The addition of surface projections to the anterior bag creates a significantly improved flow capability over the traditional spherical or ovoid shaped devices.
The anterior and posterior bags are twisted around the catheter to allow easy insertion into the nose. The posterior bag is constructed to the shape of the posterior nose and is slightly larger than the volume of the posterior nose. However, the posterior bag is not as redundantly oversized as the anterior bag. The posterior bag is not as redundant so that the bag will not extend or drop down into the throat. The anterior bag, which is more oversized, will actually flow into proximal anterior extent of the posterior nasal cavity to fill any space not occupied by the posterior bag.
The anterior and posterior bags will inflate with water or other fluid to a predetermined size and configuration. The posterior bag is not an elastic balloon, in the preferred embodiment. The anterior and posterior bags are made of medical grade silicone in the preferred embodiment.
A two channel catheter protrudes from the nostril to allow the instillation of water into each bag separately. The ends of the two channels protruding from the nose will be gradually flared to a diameter which fits over a standard hospital syringe used for irrigation or administering medication. The ends of the two channels will not have the bulky injection ports as in the XOMED(trademark) Epistat(trademark).
The existing XOMED(trademark) Epistat(trademark) has two injection ports each containing a valve which allows insertion or removal of water from the catheter. The preferred embodiment differs from the XOMED(trademark) Epistat(trademark), with a catheter which contains two lumens so water can be inserted individually into the anterior and posterior bags but does not have any valves. The two lumens are separated into two channels at the inlet of the nose to allow individual filling and clamping. After the device is inserted into the nose, a soft silicone nasal plug will be xe2x80x9csnuggedxe2x80x9d into the nostril after the common catheter has been brought out through the central channel.
The posterior bag will be inflated with water while pulling on the catheter so the posterior bag does not fall down in the throat. Once the posterior balloon is inflated, the channel to the posterior balloon is closed with a small medical clamp as the channel exits the nasal plug. The nasal plug is kept in place and the anterior bag is inflated with water with some xe2x80x9cto and froxe2x80x9d and twisting motion of the catheter to allow the redundant anterior bag to flow into the crevices. The nasal plug is kept in place as the anterior bag is filled so that the redundant anterior bag does not extrude out the nostril.
When the anterior bag is filled and the epistaxsis nosebleed is controlled, a slightly larger clamp is placed on the common catheter as both channels exit from the nasal plug. This clamp and nasal plug keeps the entire catheter/bag system from falling into the throat. Since the posterior bag will be larger in diameter than the anterior nasal airway, the posterior bag keeps the catheter/bag system from extruding out the nostril.
One embodiment of the inventive concept consists of one catheter with two anterior bags and one posterior bag. One of the anterior bags fills the right anterior nose and the other anterior bag fills the left anterior nose. The single posterior bag is designed to completely fill the posterior chamber. All bags can be filled individually through a double channel catheter which exits both nostrils. The catheter enters both the right and left airways. It has an anterior bag for both right and left anterior nasal cavities and one posterior bag for the common posterior nasal cavity. The catheter goes around the posterior septum and is secured anteriorly at the nostril with a nasal plug and clamp at both nostrils.
The individual fluid channels to the anterior and posterior bags are filled individually, clamped individually and then both clamped by a single clamp around the common catheter as it exits the nasal plug to produce a completed intra nasal pressure device. The redundancy of size and ridge projections will flow into all areas.
When the bags are filled with water, the entire system is xe2x80x9csnuggedxe2x80x9d with firmness by pulling on the combined dual common catheter while pressing inward on the nasal plug and clamping the dual common catheter with one clamp. The least complex version has one anterior bag, this device would be more effective and more convenient than other devices now available to stop the milder anterior nosebleeds.
The nasal catheter system includes; a catheter having a first anterior fluid channel, a first anterior output opening, a first anterior input port, and a first external section. There is a first anterior bag fixedly attached to the catheter. The first anterior bag has a first anterior chamber, a first outer surface, a first front end, a first middle portion and a first rear end. There is a plurality of first anterior elongated ridges attached to the first outer surface and spanning over about the first middle portion, the plurality of first anterior elongated ridges have a plurality of first anterior ridge cavities. The first anterior ridge cavities are in communication with and connected to the first anterior chamber. The nasal catheter system is inserted into a first anterior nasal cavity and then the catheter is filled with a fluid that flows through the first anterior fluid channel and into the first anterior bag, thereby expanding the first anterior bag and producing pressure upon the first anterior nasal cavity.
The nasal catheter system can additionally include a posterior fluid channel that has a posterior section, a first posterior input port and a posterior output opening. Attached to the catheter is a posterior bag with a posterior chamber. The nasal catheter system is inserted into the first anterior nasal cavity and a posterior nasal cavity so that when the posterior fluid channel is filled with a fluid, the fluid flows through the posterior fluid channel and into the posterior bag, thereby expanding the posterior bag and producing pressure upon the posterior nasal cavity.
The nasal catheter system can also be expanded to include a second anterior bag attached to a second anterior fluid channel having a second anterior output opening, a second anterior input port and a second external section. The second anterior bag has a second anterior chamber, a second outer surface, a second front end, a second middle portion and a second rear end. There is a plurality of second anterior elongated ridges attached to the second outer surface and spanning over about the second middle portion. The plurality of second anterior elongated ridges have a plurality of second anterior ridge cavities that are in communication with and connected to the second anterior chamber. The nasal catheter system may be additionally inserted into a second anterior nasal cavity and when the catheter is filled with a fluid, the fluid flows through the second anterior fluid channel and into the second anterior bag, thereby expanding the second anterior bag and producing pressure upon the second anterior nasal cavity.
The nasal catheter system can have an elongated section removably attached to the first external section or the second external section of the catheter. The elongated section may be inserted through the first anterior nasal cavity, the posterior nasal cavity and into the throat. Then a secondary member can be inserted through the second anterior nasal cavity, the posterior nasal cavity and into the throat. The secondary member is then attached to the elongated section of the catheter. Next the secondary member is pulled back through the second anterior nasal cavity, pulling the catheter, the posterior bag, the first anterior bag and the second anterior bag into the posterior nasal cavity, first anterior nasal cavity and second anterior nasal cavity.
A second posterior input port can be added to the posterior fluid channel. This allows filling of the posterior bag from either the first or second posterior input port. The first anterior bag, second anterior bag and posterior bag are made of silicone in one embodiment.
The surface projections may be arranged in a variety of configurations, including where the plurality of first anterior elongated ridges span from about the first front end to about the first rear end including the first middle portion and the plurality of second anterior elongated ridge span from about the second front end to about the second rear end including the second middle portion.
Another version has the first anterior bag with a first anterior chamber, a first long axis with a plurality of first anterior circumferencial ridges attached to a first outer surface and axially positioned in circumferencial rings about the first long axis. The plurality of first anterior circumferencial ridges span over about the first middle portion. The plurality of first anterior circumferencial ridges have a plurality of first anterior circumferencial ridge cavities. The first anterior circumferencial ridge cavities are in communication with the first anterior chamber.
The second anterior bag would have a similar arrangement with a second anterior chamber, a second long axis, a second outer surface, a second front end, a second middle portion and a second rear end. A plurality of second anterior circumferencial ridges are attached to the second outer surface and axially positioned in circumferencial rings about the second long axis. The plurality of second anterior circumferencial ridges span over about the second middle portion, the plurality of second anterior circumferencial ridges having a plurality of second anterior circumferencial ridge cavities that are in communication with the second anterior chamber.
Another version of the surface projections from the first anterior bag is a plurality of first anterior capillary tubes with a first open end and a first closed end. The plurality of first anterior capillary tubes are attached to the first outer surface and take the form of finger-like projections extending generally perpendicular from the first outer surface and spanning over about the first middle portion. The plurality of first anterior capillary tubes have a plurality of first anterior capillary tube cavities. The first open end of the first anterior capillary tube cavities are in communication with the first anterior chamber.
In a similar arrangement the second anterior bag can have a plurality of second anterior capillary tubes. The second anterior bag has a second anterior chamber, a second outer surface, a second front end, a second middle portion and a second rear end. The plurality of second anterior capillary tubes have a second open end, a second closed end and are attached to the second outer surface. The plurality of second anterior capillary tubes take the form of finger-like projections extending generally perpendicular from the second outer surface and spanning over about the second middle portion, the plurality of second anterior capillary tubes having a plurality of second anterior capillary tube cavities where the second open end of the second anterior capillary tube cavities are in communication with the second anterior chamber.
Another alternative arrangement of the nasal catheter system is where the plurality of first anterior capillary tubes span from about the first front end to about the first rear end including the first middle portion and the plurality of second anterior capillary tubes span from about the second front end to about the second rear end including the second middle portion.